Week of September 22 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• Operation Vape Trail Cracks Down on Illegal Substances in Vape Shops - DEA

Today (9/22), the Drug Enforcement Administration announced the results of a week-long operational enforcement action as part of a whole-of-government initiative aimed at removing dangerous and illegal vaping substances from communities across America. During the operation, DEA seized more than 2.3 million vape devices and cartridges and more than 100 weapons since September 15, 2025.

Vaping devices were originally designed for nicotine and marketed as a cigarette alternative. However, recent data suggests a significant portion of e-cigarette sales involve illegal substances, highlighting a growing public safety and health concern. Also being sold in vape shops are illegal and addictive substances such as synthetic marijuana, synthetic cathinones, and hydroxymitragynine, also known as 7-OH or synthetic kratom. Many of these products feature bright packaging and imagery inspired by popular cereals, candies, and snacks, which appeal to young people.

• Altria Enters Memorandum of Understanding With KT&G to Pursue Long-term Adjacent Growth - Altria

Altria Group, Inc. (Altria) (NYSE:MO) today announces that we have entered into a non-binding Global Collaboration Memorandum of Understanding (the MOU) with KT&G Corporation (KT&G), a top-tier global tobacco and consumer products company, to use the companies’ complementary strengths and offerings in the joint pursuit of long-term growth opportunities with modern oral nicotine products, non-nicotine products and operating efficiency in traditional tobacco.

The MOU aligns with Altria’s pursuit of its long-term adjacent growth goals in international innovative smoke-free products and non-nicotine products that we announced in March 2023.

• New Materials Posted for Philip Morris’ MRTP Renewal Applications for IQOS Products On September 25, 2025, FDA posted new materials related to the modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products S.A. for several IQOS heated tobacco products. - FDA

FDA previously issued modified risk granted orders (MRGOs) authorizing Philip Morris Products S.A. to market the following products with specific reduced exposure claims:

• IQOS 2.4 System Holder and Charger and HeatSticks (Authorized July 7, 2020)

• IQOS 3.0 System Holder and Charger (Authorized March 11, 2022)

These products were authorized to be marketed with the following reduced exposure information:

“AVAILABLE EVIDENCE TO DATE:

• The IQOS system heats tobacco but does not burn it.

• This significantly reduces the production of harmful and potentially harmful chemicals.

• Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.” 

A Tobacco Product Scientific Advisory Committee (TPSAC) hearing will be held on October 7, 2025 to discuss the renewal of modified risk granted orders issued to Philip Morris Products S.A. (See analysis below)

• Illicit market pressures e-cigarette sales - CSP

“Illicit e-vapor penetration is roughly 70% today, though we expect this to fall through 2035,” Herzog said.“While more retailers are becoming optimistic that pressures from illicit e-vapor will ease in 2025, most are still negative in their outlooks for the remainder of the year,” she said.

On Monday, the Drug Enforcement Administration (DEA) announced the results of a week-long operational enforcement action dubbed Operation Vape Trail. During the operation, DEA seized more than 2.3 million vape devices and cartridges since Sept. 15.